- Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports
- Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers
- Experience in reviewing of quality documents such as Reformulation studies, process validations, particle size method implementation and specification, stability indicating methods implementation, impurity
- Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle as needed for product in-license/due diligence review, product divestment and product withdrawal.
- Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
- Planning the project by understanding the client needs, managing project deliverables and providing solutions in real time.
- Collaborate with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
- Manage execution / authoring of CMC documentation (Module 1 , 2 and 3) for life cycle management - post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
- Knowledge of regulatory guidelines and relevant applications.
- Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
- Deliver all regulatory milestones for assigned products across the product lifecycle, Deliver on agreed SLAs with clients at contract and account/ project level. Meet all monthly reporting/business metrics/KPIs requirements and manage internal control processes.
- Identify, communicate and escalate potential regulatory issues / risks and propose mitigation.
- Ensure established policies and procedures of the organization/client are followed and ensure compliance.
- Demonstrate oral and written communication skills and the ability to communicate issues in a succinct and logical manner.
- Demonstrate ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
- Demonstrate flexibility in responding to changing priorities, multi-tasking and dealing with client expectations.
- Demonstrate effective leadership, communication, interpersonal skills, and soft skills.
- Bachelor's or masters degree required in science, engineering or related field (advanced degree preferred).
- Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields
- Marketing authorization experience.
- Proven Project Management experience Skills:
-
Google New York, United States**Minimum qualifications**: · - Bachelor's degree in a relevant field, or equivalent practical experience. · - 5 years of experience in program management. · - Experience managing programs and processes across distributed systems. · **Preferred qualifications**: · - Master's degr ...
-
Software Engineer III
1 week ago
myGwork - LGBTQ+ professionals & allies Jersey City, United StatesThis inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community. · We have an exciting and rewarding opportunity for you to take your software engineering career to the next level. · As a Software Engineer III at JPMorgan Chase wit ...
-
Software Engineer III
1 week ago
Marathon TS Jersey City, United StatesJob Description · Software Engineering - III · Marathon TS is seeking a Software Engineer to fulfill a position for the Mission Assurance (MA) Department in support of the development and sustainment of the U.S. Navy Aegis Weapons System in Moorestown, NJ. · Performs subsystem d ...
-
Software Engineer III
6 days ago
Veterans Sourcing Group LLC Jersey City, United StatesSoftware Engineer III · Jersey City (Hybrid) · The position will participate in the development, implementation, and on-going maintenance of the Bank's application software. The department / team will work across all business units of the Bank to address Information Technology pr ...
-
Software Engineer III
4 weeks ago
JPMorgan Chase Bank, N.A. Jersey City, United StatesApply your skillsets to drive innovation and modernize the world's most complex and mission-critical systems · There's nothing more exciting than being at the center of a rapidly growing field in technology and applying your skillsets to drive innovation and modernize the world' ...
-
Security Engineer III
5 days ago
JPMorgan Chase Bank, N.A. Jersey City, United StatesYour seniority as a security engineer puts you in the ranks of the top talent in your field. Play a critical role at one of the world's most iconic financial institutions where security is vital. · As a Security Engineer III at JPMorgan Chase within Cybersecurity and Technology ...
-
Engineer III
1 week ago
HNTB New York, United StatesAt HNTB, you can create a career that is meaningful to you while building communities that matter to all of us. For more than a century, we have been delivering solutions for some of the largest, most complex infrastructure projects across the countr Engineer, Bridge, Staffing, C ...
-
Engineer III
2 weeks ago
Acquired Data Solutions Atlantic City, United StatesJob Description · Job DescriptionMUST HAVE CURRENT DHS SUITABILITY OR CURRENT SECRET CLEARANCE AT OTHER GOVERNMENT AGENCIES. · Mid Level (6-12 years experience) · Acquired Data Solutions, Inc. is a test and engineering company that is seeking an onsite Mid Level Engineer to join ...
-
Systems Engineer III
1 week ago
Saxon Global Jersey City, United StatesHey Team, · Have a great role for a Cohesity Back Up NEgineer with BNY · HYBRID IN JERSEY 1-3 times a week · Needs are: · Architecture experience · VMware vcenter systems · PYTHON OR PERL · L3 Supports · COHESITY · rate is 100 · Cohesity Backup Engineer · Team Descript ...
-
Engineer III
1 week ago
HNTB Corporation Newark, United StatesWhat We're Looking For · At HNTB, you can create a career that is meaningful to you while building communities that matter to all of us. For more than a century, we have been delivering solutions for some of the largest, most complex infrastructure projects across the country. Wi ...
-
Engineer III
1 week ago
HNTB Newark, United StatesPosition or Keyword (Leave blank to see all) · What We're Looking For · At HNTB, you can create a career that is meaningful to you while building communities that matter to all of us. For more than a century, we have been delivering solutions for some of the largest, most complex ...
-
Engineer III
6 days ago
HNTB Newark, United StatesWhat We're Looking For · At HNTB, you can create a career that is meaningful to you while building communities that matter to all of us. For more than a century, we have been delivering solutions for some of the largest, most complex infrastructure projects across the country. Wi ...
-
Software Engineer III
1 week ago
Walmart Hoboken, United States Full timePosition Summary... · What you'll do... · As a Software Engineer III on the Walmart Commerce Technologies team you will have the opportunity to work on commercializing mature enterprise systems and enabling them for retailers. You will build a new SaaS product and ensure engineer ...
-
Quality Engineer III
4 days ago
Walmart Hoboken, United StatesPosition Summary... · What you'll do... · As a member of the Health and Wellness Quality Engineering group, you'll be responsible for test designing, test execution, and find defects using both manual and automation that can directly improve our customers' lives. You'll indepen ...
-
Quality Engineer III
3 days ago
Wal-Mart Stores , Inc. Hoboken, United StatesLocation HOBOKEN, NJ Career Area Software Development and Engineering Job Function Quality Engineering Employment Type Regular/Permanent Position Type Salary Requisition WD What you'll do at Position Summary...What you'll do...As a member of the Health and Wellness Quality Engine ...
-
Quality Engineer III
4 days ago
Walmart Hoboken, United StatesWhat you'll do at · Position Summary... · What you'll do... · As a member of the Health and Wellness Quality Engineering group, you'll be responsible for test designing, test execution, and find defects using both manual and automation that can directly improve our customers' ...
-
Software Engineer III
4 days ago
Walmart Hoboken, United States Full timeLocationHOBOKEN, NJCareer AreaSoftware Development and EngineeringJob FunctionSoftware Engineering and ArchitectureEmployment TypeRegular/PermanentPosition TypeSalaryRequisitionWD What you'll do at Position Summary .What you'll do .As a Software Engineer III on the Walmart Commer ...
-
Electrical Engineer III
3 weeks ago
Strata Clean Energy New York, United StatesStrata Clean Energy is a leading developer, EPC, and service provider for utility-scale solar and storage systems in the United States. We control and self-perform all processes from our nationwide solar and storage developments, to construction, O&M, and Asset Management. · Our ...
-
Systems Engineer III
3 weeks ago
Capital Staffing Solutions New York, United StatesSystems Engineer III · HYBRID – Two days onsite in Melbourne or Miramar, FL · 6-Month Contract-to-Hire · Seeking a candidate that can automate deployment functions · Must be able to create scripts and troubleshoot scripts (more experience is better) vs someone that only knows h ...
-
Software Engineer III
3 weeks ago
Fanatics New York, United StatesJob Description · Overview · As Software Engineer III - Middlewares at Fanatics Betting & Gaming (FBG), you are here to help build out our Data Platform Engineering team. This role reports to our Director of Platform Engineering and is responsible for defining, implementing, tr ...
Network Engineer III - Jersey City, United States - Ask Staffing
Description
Job Title:
CMC 3 Manager- Regulatory Affairs
Bill rate :
$79.87/hr
Responsibilities
Minimum qualifications
Bachelor's or master?s degree required in science, engineering or related field (advanced degree preferred).
Preferred Qualifications
Name
Required
Importance
Experience
No items to display.